Cleared Traditional

K040047 - POLYGRAFT BGS

Also marketed or referenced as:
BONE GRAFT SUBSTITUTE

K040047 is an FDA 510(k) clearance for POLYGRAFT BGS, manufactured by Osteobiologics, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K040047 · Osteobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
340d
Days
Class 2
Risk

K040047 is an FDA 510(k) clearance for the POLYGRAFT BGS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Osteobiologics, Inc. (San Antonio, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteobiologics, Inc. devices

FDA 510(k) Submission Details - K040047

510(k) Number K040047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2004
Decision Date December 17, 2004
Days to Decision 340 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 122d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 327
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K040047.
ALLOGRAN-N-BONE VOID FILLER
K043514 · Biocomposites, Ltd. · Jan 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
BF+
K043347 · Ldr Spine USA · Jan 2005
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · Biomet Manufacturing, Inc. · Aug 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · Novabone Products, LLC · Aug 2004